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510(k) DEN170058

MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay by Memorial Sloan-Kettering Cancer Center — Product Code PZM

DEN170058 is an FDA 510(k) premarket notification submitted by Memorial Sloan-Kettering Cancer Center for the device "MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay". The FDA issued a decision of De Novo Granted on November 15, 2017. The device falls under product code PZM (Next Generation Sequencing Based Tumor Profiling Test), a Class II device regulated under 21 CFR 866.6080.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 15, 2017
Date Received
September 25, 2017
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Next Generation Sequencing Based Tumor Profiling Test
Device Class
Class II
Regulation Number
866.6080
Review Panel
PA
Submission Type

A next-generation sequencing based tumor profiling test is a qualitative in vitro diagnostic test intended to detect mutations in a broad panel of targeted genes that are somatically altered in malignant neoplasms from tumor specimens obtained from patients diagnosed with malignant solid neoplasms using targeted next-generation sequencing.

Other clearances for product code PZM

  • K260235 — CellDx-Tissue (May 12, 2026)
  • K241868 — xR IVD (September 19, 2025)
  • K250003 — GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) (August 29, 2025)
  • K210017 — ACTOnco, ACTOnco IVD (December 23, 2022)
  • K202304 — NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) (July 14, 2021)
  • K192063 — PGDx elio tissue complete (April 24, 2020)
  • K190661 — Omics Core (November 9, 2019)

FDA data resources